RecruitingNot ApplicableNCT06473987

Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance

Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance in People with Traumatic Brain Injury

Sponsor

Kessler Foundation

Enrollment

135 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury

Summary

Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury. The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria11

Be between 18-65 years of age.
Be a person living with TBI for at least 6 months.
Be able to follow directions and commands.
Be able to speak and understand English well as evaluated by a test I will be given by the researchers.
Not have amnesia (as determined by study staff based on a Post Traumatic Amnesia O-log score of > 20 on 2 consecutive days)
Have approval from a physician to participate.
Have no history of injury or problems with my legs in the past 6 months or any medical issue which would interfere with my ability to bear weight on my legs and walk (such as a bone or muscle injury).
No double vision (diplopia) or other vision problems (such as nystagmus, as determined by study staff)
Have joint passive range of motion within normal functional limits for walking as determined by study staff.
Have a walking speed of less than 0.8 m/s as determined by study staff.
Be able to stand for 5 minutes.

Exclusion Criteria8

I have uncontrolled or unstable seizure disorder (such as epilepsy).
I have pre-existing condition that makes it difficult for me to exercise (such as diagnosed high blood pressure that is not controlled, heart disease, irregular heart rate or rhythm, or congestive heart failure).
I have muscle or nervous system problems other than TBI (such as spinal cord injury, multiple sclerosis, or Parkinson's disease)
Have any joint or muscle tightness that would limit my movement while walking.
I have any medical issue that prevents me from supporting my weight (such as bone or muscle injuries, pain, or severe muscle spasms).
I have been diagnosed with cognitive (thinking) problems prior to TBI.
I have severe dizziness (Dizziness Handicap Inventory score greater than 54 (as measured by study staff).
I have skin issues that would prevent me from wearing a safety harness.